Biokyra

Sunday, July 24, 2016

How will Brexit affect Europe’s medical device industry?

After the United
Kingdom’s vote to leave the European Union, uncertainty has become the norm.
Erik Vollebregt, a founding partner of life sciences law firm Axon (Amsterdam),
writes on his medicaldeviceslegal website that medical device companies
are asking him “what this means for CE marks for medical devices and for the
process of the [new medical device and in vitro diagnostics regulations] as
well as medical device law and policy in the EU, in general.”

It’s unlikely that the
so-called Brexit will have any impact on the new medical device and in vitro
diagnostics regulations (expected to be adopted by the European Council and
Parliament this year). “The EU will certainly not suspend the project because
of the Brexit because the texts were established following the normal
legislative procedure. The texts will enter into force in the EU as planned and
may also take effect even in the UK, up until the date on when the UK formally
disengages from EU law,” writes Vollebregt.

The United Kingdom
still has to trigger Article 50 of the Lisbon Treaty, formally starting the
process of withdrawal from the European Union. Until that happens, nothing
changes. Even when the UK government pulls the trigger, “the law calls for a
two-year process, and the adoption of the new medical device and IVD
regulations will be well underway at that point.”

The main question
across the globe is what type of relationship the United Kingdom will have with
the European Union after it pulls out:one possible outcome is
the signing of a mutual recognition agreement along the lines of the treaty
that Switzerland has with the EU. “That agreement allows Switzerland to have
notified bodies and provides for mutual recognition of the CE mark,” notes Vollebregt.

For the time being,
until the final breakup, “British legislation remains fully aligned with
European rules and CE marked products can move freely across the Channel.”

No one really knows
where this uncertainty is heading – causing a lot of headaches throughout the
global manufacturing, business and financial communities.